Melatonin in Epilepsy: Trial of Melatonin as add on anti-seizure medication in Epilepsy patients

Efficacy of add on Melatonin on seizure outcome in Focal drug resistant epilepsy patients : A Randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072001

Enrollment

126

Registered

2024-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset Health Condition 2: G402- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures Health Condition 3: G401- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures

Interventions

Intervention1: Melatonin: Patients in the intervention arm will receive add on melatonin 3 mg daily orally for 12 weeks in addition to the existing drug regimen. Control Intervention1: placebo: patien

Eligibility

Inclusion criteria

Inclusion criteria: 1.Focal drug resistant epilepsy patients on stable treatment during previous month 2. Recent seizure attacks [ = 3 seizures per month / clusters of seizures]

Exclusion criteria

Exclusion criteria: 1.Primary sleep disorders like severe OSA, narcolepsy, cataplexy 2. Major depression 3. Neuroendocrine tumors 4. Rapidly growing brain tumors 5. Uncontrolled diabetes 6. Hepatic dysfunction 7. Severe asthma 8. Infertility 9. Pregnancy and nursing women

Design outcomes

Primary

Measure	Time frame
responder rateTimepoint: 3 months	—

Secondary

Measure	Time frame
seizure free rate, seizure severity, sleep parameters, quality of lifeTimepoint: 3 months	—

Countries

India

Contacts

Public ContactUppula Supriya

AIIMS,DELHI,INDIA

supriyauppula@gmail.com7601031906

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026