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NCT02343159
Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
Phase 4 trial testing dimethyl fumarate in Multiple Sclerosis in 84 participants. Terminated before completion.
15 April 2016
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 84 |
| Start date | 28 February 2015 |
| Primary completion | 15 April 2016 |
| Estimated completion | 15 April 2016 |
| Sites | 29 locations across United States |
Drugs / interventions tested
- dimethyl fumarate (DIMETHYL FUMARATE) — full drug profile →
- Medication Event Monitoring System (MEMS)
- Adherence counseling
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Biogen — full company profile →
Who can join
Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Collected between the time of informed consent and month 12 or early discontinuation visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (5 terms)
| Reaction | System | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Co… |
|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | — | — | — |
| Encephalopathy | Nervous system disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Intentional overdose | Injury, poisoning and procedural complications | — | — | — |
| Toxicity to various agents | Injury, poisoning and procedural complications | — | — | — |
Other adverse events (75 terms — click to expand)
| Reaction | System | Arm 1: Standard MEMS Cap | Arm 2: Smart MEMS Cap | Arm 3: Smart MEMS Cap + Co… |
|---|---|---|---|---|
| Flushing | Vascular disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Seasonal allergy | Immune system disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Multiple sclerosis relapse | Nervous system disorders | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — | — |
| Pruritis | Skin and subcutaneous tissue disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Fungal infection | Infections and infestations | — | — | — |
| Herpes zoster | Infections and infestations | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — | — |
| Allergy to arthropod sting | Immune system disorders | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | — | — | — |
| Bruxism | Psychiatric disorders | — | — | — |
| Depression | Psychiatric disorders | — | — | — |
| Obsessive-compulsive disorder | Psychiatric disorders | — | — | — |
| Stress | Psychiatric disorders | — | — | — |
| Suicidal ideation | Psychiatric disorders | — | — | — |
| Suicide attempt | Psychiatric disorders | — | — | — |
| Balance disorder | Nervous system disorders | — | — | — |
| Disturbance in attention | Nervous system disorders | — | — | — |
| Dizziness | Nervous system disorders | — | — | — |
| Encephalopathy | Nervous system disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Hypoaesthesia | Nervous system disorders | — | — | — |
| Neuralgia | Nervous system disorders | — | — | — |
| Visual acuity reduced | Eye disorders | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — |
| Hot flush | Vascular disorders | — | — | — |
| Bone contusion | Injury, poisoning and procedural complications | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — |
Most-reported serious reactions: Suicide attempt, Encephalopathy, Vomiting, Intentional overdose, Toxicity to various agents.
Data from ClinicalTrials.gov NCT02343159 adverse events section.
Sponsor's own description
The primary objective of the study is to determine whether a Medication Event Monitoring System (MEMS®) cap with a liquid crystal display (LCD) reader (a "smart" cap) along with additional patient counseling intervention (Arm 3) can improve adherence to dimethyl fumarate (DMF) treatment in Multiple Sclerosis (MS) patients as compared to a MEMS cap without an LCD reader (a "standard" cap) and no patient counseling intervention (standard of care, Arm 1) at Month 12. The secondary objectives of this study in this study population are: to determine if data display on a smart MEMS cap with an LCD reader (Arm 2) can improve adherence as compared to a standard MEMS cap without an LCD reader (Arm 1) at Month 12; to determine whether the addition of patient counseling intervention based on MEMS data (Arm 3), or data display from a MEMS cap with an LCD reader (Arm 2) can improve adherence compared to standard MEMS cap without an LCD reader (Arm 1) at Month 6; to assess persistence and compliance at Months 6 and 12 for all arms; to assess the association between adherence and patient- reported outcomes (PROs) for all arms including Multiple Sclerosis Impact Scale (MSIS-29), and the Work Productivity and Activity Impairment Questionnaire (WPAI): MS v2.0.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Induction of Cardiac Pathology: Endogenous versus Exogenous Nrf2 Upregulation.
Mathis BJ, Kato H, Hiramatsu Y. · · 2022 · cited 5× · PMID 36497112 · DOI 10.3390/cells11233855
Verify or expand the search:
- PubMed search for NCT02343159
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02343159 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biogen
- Last refreshed: 16 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02343159.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing