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Effect of Melatonin on the Daytime Sleepiness side-effect of Gabapentin in Patients With Neuropathic Pain

Effect of Melatonin on the Daytime Sleepiness side-effect of Gabapentin in Adult Patients With Neuropathic Pain

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000522213
Acronym
MGT
Enrollment
80
Registered
2018-04-09
Start date
2018-04-23
Completion date
2018-05-16
Last updated
2019-07-15

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

Conditions

None listed

Brief summary

In this study, our primary hypothesis is: “Melatonin may decrease daytime sleepiness, the most frequent adverse effect of gabapentin, and improve the quality of sleep in patients with neuropathic pain”. Our secondary hypothesis is: “Melatonin may help in the attenuation of neuropathic pain of gabapentin and sleep quality in patients with neuropathic pain”.

Interventions

Patients suffering from “neuropathic pain” and planed to receive gabapentin therapy will be included in the study. The patients will be randomly divided into two groups based on a software program; group 1 (melatonin +/receive melatonin) and group 2 (melatonin -/receive placebo). All patients will receive oral gabapentin therapy (Neurontin®, Pfizer, Turkey) as day 1, 300 mg; day 2, 600 mg (300 mg two times per day); day 3, 900 mg (300 mg, three times per day) and 900 mg (300 mg, three times per

Patients suffering from “neuropathic pain” and planed to receive gabapentin therapy will be included in the study. The patients will be randomly divided into two groups based on a software program; group 1 (melatonin +/receive melatonin) and group 2 (melatonin -/receive placebo). All patients will receive oral gabapentin therapy (Neurontin®, Pfizer, Turkey) as day 1, 300 mg; day 2, 600 mg (300 mg two times per day); day 3, 900 mg (300 mg, three times per day) and 900 mg (300 mg, three times per day) thereafter. Patients in group 1 (melatonin +) will receive 3 mg melatonin (Melatonina®, Interpharm, Turkey) orally 60 minutes before bedtime starting from the first day of gabapentin therapy While patients in group 2 (placebo) will receive matching placebo capsules 60 min before bedtime. Melatonin therapy will continue for 30 days while gabapentin therapy will last for 3 months. A calendar with two boxes for each study drug under each day, will be given to all of the patients. The patients will be asked to fill in the related boxes if they remember to take their drugs on that day. The calendars will be checked on 10th and 30th days to monitor adherence to the therapy.

Sponsors

Basak Altiparmak
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Patients suffering from “neuropathic pain” and planed to receive gabapentin therapy will be consecutively included in the study

Exclusion criteria

Patients with sleep apnea syndrome, liver disease, chronic kidney disease, abnormal thyroid hormone levels, anemia, preexisting gabapentin consumption and patients under insomnia therapy will be excluded from the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026