Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07301632 | Ecstasy to Alleviate SEvere Chronic Neuropathic Pain Trial | PHASE2 | RECRUITING | 40 | — | — | Jan 30, 2026 | Dec 1, 2028 | Feb 13, 2026 | 1 | Canada |
Average Monthly recruitment of \>1 participant per center means that the full trial should meet recruitment requirements within 12 months.
Data completion rate (of primary clinical outcome)≥ 80%
Retention of ≥80% of participants at the reported primary outcome point of 16 weeks after the experimental session should minimize attrition bias in the definitive trial's primary outcome data (e.g. withdrawal due to side-effects)
Blinding Integrity (≤80% of participants in both arms correctly guess their treatment allocation (Note: 50% of participants would be expected to correctly guess treatment allocation due to chance alone)
≤3 serious drug-related adverse events
| Arm | Type | Description |
|---|---|---|
| 3,4-Methylenedioxymethamphetamine | ACTIVE_COMPARATOR | Treatment Arm: 3,4-Methylenedioxymethamphetamine 120mg (3 x 40mg capsule) PO single dose plus psychological support; optional 40mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose 160mg) |
| Methylphenidate | PLACEBO_COMPARATOR | Placebo arm: Methylphenidate 30mg (3 x 10mg capsule) PO single dose plus psychological support; optional 10mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose of 40 mg) |
| Name | Type | Description |
|---|---|---|
| 3,4-Methylenedioxymethamphetamine | DRUG | Treatment arm: 3,4-Methylenedioxymethamphetamine 120mg (3 x 40mg capsule) PO single dose plus psychological support; optional 40mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose 160mg) |
| Methylphenidate | DRUG | Placebo arm: Methylphenidate 30mg (3 x 10mg capsule) PO single dose plus psychological support; optional 10mg supplemental dose at 2hr mark if there are no tolerability issues reported, patient consents and lead physician deems appropriate. (Maximum dose of 40 mg) |
Inclusion Criteria: * Consenting adults 18 years and older. * Diagnosis of chronic neuropathic pain (greater than 3 months in duration) by a clinician with specialized training in chronic pain, confirmed with the standardized Leeds Assessment of Neuropathic Symptoms and Signs questionnaire. * Suffe...