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NCT01122381
Pharmacologic and Genetic Evaluation of a C. Elegans Model for Migraine
Phase 1/Phase 2 trial testing ethosuximide in Headache, Migraine in 5 participants. Terminated before completion.
1 April 2014
Quick facts
| Lead sponsor | US Department of Veterans Affairs |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 5 |
| Start date | 1 December 2011 |
| Primary completion | 1 April 2014 |
| Estimated completion | 1 April 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ethosuximide (Ethosuximide) — full drug profile →
- placebo comparator
Conditions studied
- Headache, Migraine — all drugs for Headache, Migraine →
Sponsor
US Department of Veterans Affairs
Who can join
Adults 18 to 65, any sex, with Headache, Migraine. 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.
-
Migraine Headache Days Per 4 Week Period Comparing the Last 4 Weeks of Treatment to a 4 Week Pre-treatment Baseline.
Time frame: 4 weeks, end of treatment and pre-treatment baseline
Compare number of migraine headache days pre and post treatment between the ESX and placebo group. Study terminated early-no outcome data available. The single subject assigned to study drug did not actually take it according to subsequent review of ESX drug levels.
Sponsor's own description
The purpose of this study is to determine whether ethosuximide works better than placebo in the prevention of episodic migraine among veterans.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01122381
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ethosuximide
Trials testing the same drug.
- NCT04217733 — Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome · Phase 3 · recruiting
- NCT03196466 — Population Pharmacokinetics of Antiepileptic in Pediatrics · completed
Other recruiting trials for Headache, Migraine
Currently open trials in the same condition.
- NCT06584409 — Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP · NA · recruiting
- NCT05889624 — Responding With Evidence and Access for Childhood Headaches · NA · recruiting
- NCT05232942 — Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption · recruiting
- NCT04715685 — Mind Body Balance for Pediatric Migraine · NA · recruiting
Other US Department of Veterans Affairs trials
Trials by the same sponsor.
- NCT06068699 — Postcards to Improve Remote Monitoring Adherence Among Veterans · NA · completed
- NCT00262496 — Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach. · Phase 2 · withdrawn
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 NCT01122381 (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 US Department of Veterans Affairs
- Last refreshed: 11 August 2015
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/NCT01122381.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing