Last reviewed · How we verify
NCT02090725: 3-4DAP
Controlled Trial of 3,4-Diaminopyridine in LEMS
Phase 2 trial testing 3-4 Diaminopyridine in Muscle Weakness in 4 participants. Terminated before completion.
1 July 2018
Quick facts
| Lead sponsor | Jeffrey A. Cohen, MD |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 1 February 2004 |
| Primary completion | 1 July 2018 |
| Estimated completion | 28 November 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 3-4 Diaminopyridine
Conditions studied
- Muscle Weakness — all drugs for Muscle Weakness →
Sponsor
Jeffrey A. Cohen, MD
Who can join
Adults 45 to 65, any sex, with Muscle Weakness. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants That Showed Improvement in Muscle Weakness During Their Last Study Related Visit
Time frame: Participants were followed until they withdrew or the study ended. Time frame ranged from 1 month to 3 years.
Muscle weakness will be assessed monthly for the first 3 months based on clinical assessment during office visits. Muscle weakness will then be assessed every 6 months once the patient is stabilized based on clinical assessments during office visits. The assessment of whether there was an improvement in muscle weakness, based on the PI's clinical judgment, was noted during the last study visit com
Sponsor's own description
The main purpose for this study is to provide access to 3,4 DAP, a drug which has demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and autonomic dysfunction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02090725
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Muscle Weakness
Currently open trials in the same condition.
- NCT06998134 — Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults · recruiting
- NCT07103499 — Abdominal and Core Exercises on Respiratory Functions in Obese and Overweight Women (COREBREATH) · NA · recruiting
- NCT07292311 — Reliability of Muscle Strength and Activation Assessment Tools and Effects of an Online Therapeutic Exercise Program in · NA · active not recruiting
- NCT07026084 — Effects of Biofeedback-Guided Training on Muscle Strength and Postural Alignment in Upper Cross Syndrome. · NA · recruiting
- NCT06205147 — Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly. · NA · recruiting
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 NCT02090725 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jeffrey A. Cohen, MD
- Last refreshed: 1 May 2019
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/NCT02090725.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing